Pharmacy Prior Authorization Criteria

Trikafta (elexacaftor/tezacaftor/ivacaftor)

For diagnosis of Cystic Fibrosis
Indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data.

*Please consult Background section for table of CFTR gene mutations responsive to Trikafta.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

AND

Patient has at least one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as detected by a FDA-cleared cystic fibrosis mutation test or a test performed at a Clinical Laboratory Improvement Amendments (CLIA)-approved facility:*

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

Patient demonstrates positive clinical response to therapy (e.g., improvement in lung function [percent predicted forced expiratory volume in one second {PPFEV1}] or decreased number of pulmonary exacerbations) [1,2]

2024-11-04, 2023-10-27, 2023-05-16, 2022-10-31, 2021-11-03, 2021-08-16, 2021-02-04, 2020-10-27, 2019-10-30

Trikafta Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. August 2023.
Keating D, Marigowda G, Burr L, et al. VX-445–tezacaftor–ivacaftor in patients with cystic fibrosis and one or two Phe508del alleles. N Engl J Med. 2018;379:1612-20.

2024-11-04: Annual review: No criteria changes.
2023-10-27: Annual review: Updated reauthorization criteria verbiage to "Patient demonstrates positive clinical response to therapy." Updated references.
2023-05-16: Added in new granule formulation and added age criteria to guideline
2022-10-31: Annual review: No criteria changes.
2021-11-03: 2021 Annual Review, no changes to criteria.
2021-08-16: Updated guideline with new lower strength dose pack (50-25-37.5 mg, 75mg) and expanded indication to patients 6 years of age.
2021-02-04: Updated criteria and included background table due to expanded indication approved for additional mutations. Removed reference to drug name from reauth criteria.
2020-10-27: 2020 Annual Review, no changes to criteria.
2019-10-30: New drug guideline